HoarsenessHoarsenessNCT05996146
Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
An observational study of Hoarseness, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hoarseness
- How many people
- 427 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 May 2022to 31 Jul 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions and visit at Seoul National University Hospital. Patients who voluntarily consent to participate in the study
Who may be able to join
- Age range is 20 to 80 years old
- degenerative spine conditions
- visit at Seoul National University Hospital only
- Patients who voluntarily consent to participate in the study
Who cannot join
- History of surgery around the airway or mediastinum
- patients with vocal cord-related disorders
- Patients with fractures, bleeding, or other trauma
- Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
- Patients who cannot be extubated or who are transferred to the ICU after surgery
- Pregnant women
- Patients who do not wish to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.
Read the detailed description
The primary outcome of this study is the incidence of hoarseness on the day of surgery.
The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.
Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.
- Conditions
- Hoarseness
- Keywords
- hoarseness, spine surgery
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hoarseness group | This study recruited all patients admitted at Seoul National University Hospital. Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions. Patients who voluntarily consent to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome was to measure the incidence of hoarseness
the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia
Measured: voice recordings six hours after the end of anesthesia
Secondary outcomes (1)
The secondary outcome involved measuring the incidence of hoarseness one month after the surgery
analyzed the correlation between Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scores and voice acoustic parameter analysis
Measured: one month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start5 May 2022
- Primary completion27 Nov 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HoarsenessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
- Investigators
- SUM KIM, Dr, Principal investigator, Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996146
- Sponsor's protocol ID
- HA-427
- Acronym
- Hoarseness
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05996146
- Acronym / sponsor ID
- Hoarseness / HA-427
- Conditions
- Hoarseness
- Keywords
- hoarseness, spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.
Detailed description
The primary outcome of this study is the incidence of hoarseness on the day of surgery.
The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.
Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hoarseness group | – | –This study recruited all patients admitted at Seoul National University Hospital. Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions. Patients who voluntarily consent to participate in the study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions and visit at Seoul National University Hospital. Patients who voluntarily consent to participate in the study
Key inclusion criteria (4 listed)
- Age range is 20 to 80 years old
- degenerative spine conditions
- visit at Seoul National University Hospital only
- Patients who voluntarily consent to participate in the study
Key exclusion criteria (7 listed)
- History of surgery around the airway or mediastinum
- patients with vocal cord-related disorders
- Patients with fractures, bleeding, or other trauma
- Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
- Patients who cannot be extubated or who are transferred to the ICU after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the primary outcome was to measure the incidence of hoarseness
Time frame: voice recordings six hours after the end of anesthesia
the primary outcome was to measure the incidence of voice disorders by conducting Voice Handicap Index-10 (minimum score 0 to maximum score 46, lower score is better) scoring and voice recordings six hours after the end of anesthesia
1 secondary outcome
The secondary outcome involved measuring the incidence of hoarseness one month after the surgery
Time frame: one month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SUM KIM, Dr principal investigator
Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hoarseness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary outcome was to measure the incidence of hoarseness (time frame: voice recordings six hours after the end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.